BRPI0719231A2 - DISTORATED PERISTALTIC MICRO PUMP FROM AN INTERCHANGEABLE PUMP HEAD - Google Patents

Description

Report of the Invention Patent for "DISTRIBUTED PERISTALTIC MICROBUMB OF AN EXCHANGIBLE PUMP HEAD".

The present invention relates to a device for injecting a pharmaceutical product into a human or animal body by means of a simple and rapidly interchangeable motorized pump head.

Many pharmaceutical products must be injected into the body. This applies in particular to those who are inactivated or who crucially lose their activity with oral administration. Said pharmaceutical products include in particular proteins (such as, for example, insulin, growth hormones, interferons), carbohydrates (e.g., heparin), antibodies or most vaccines. Syringes, drug pens or drug pumps are predominantly used for injection into the body.

The conventional insulin injection device is a syringe

of insulin. It has been used since the beginning of insulin therapy, but has recently been replaced in stages by the introduction of an insulin pen, especially in Germany. However, syringes are currently irreplaceable, for example if an insulin pen is lost or defective, and are used by many diabetics in combination with insulin pens. Freedom of maintenance and universal availability are advantageous, especially during travel.

Insulin syringes differ in their designation and grade according to the insulin concentration to be used, U40 or U100. Insulin 25 can be obtained either from vials or from pre-filled insulin pen cartridges. This makes it possible to mix different types of insulin and reduce the number of injections required. Particular attention should be paid to the care of bubble release when insulin is taken into the syringe. The directly visible insulin dose that has been sorbed makes it possible for the user to easily check the amount of insulin injected. However, technique and regular use are necessary for error-free administration with insulin syringes. An additional injection device that is now widely used around the world and especially in Europe is the insulin pen.

This medical device, which is the size of a highlighter pen, was developed in the mid-1980s and is mainly used for more intense insulin therapy. A substantial innovation compared to insulin syringes is the use of an interchangeable medication container. Said container, also called a cartridge, is filled with insulin when supplied by the manufacturer and is inserted into the insulin pen prior to use. When the pen is operated, a needle punctures the cartridge sealing disc and achieves parenteral injection of the preselected dose in insulin administration. An injection and release mechanism generates during injection an injection stroke that advances a plunger or stopper into the cartridge and causes the preselected dose to be delivered into the target tissue. The mechanism generally consists of a rigid piston rod of an overall length corresponding to the stroke of the cartridge stop.

Insulin pens are divided into disposable and reusable ones. In the case of disposables, the cartridge and the measuring mechanism form a unit prefabricated by the manufacturer and are discarded together 20 after the cartridge is emptied. Reuse of the measuring mechanism is not intended. Unlike pre-filled pens, reusable pens have a higher user demand. Thus, when the cartridge is changed, the plunger rod must be retracted to the initial position. This occurs, depending on the model, by twisting or sliding the plunger rod while simultaneously triggering a special function in the measuring mechanism. This should be done very carefully by the user because malfunction, eg plunger rod adhesion, may occasionally occur due to daily use and high mechanical stresses.

Reusable insulin pens are further divided

on hand and semi-automatic pens. In the case of hand pens, the user exerts a finger force to press the injection button and thus determines the duration and progress of the injection. In contrast, with semi-automatic insulin pens, use is preceded by manual spring tensioning that stores the energy required for injection. In the current injection step, the spring is released by the user. The speed of injection is fixed by the power of the spring and cannot be adapted to personal needs.

DE 19 745 999 describes a compact tube pump of particularly smaller construction. Said pipe pump is said to consist of a send head, a send head driver, a revolution coefficient controller and other components and accessories, the pipe pump being distinguished by the pump head being easy - Removable with relevant direction from housing and being replaceable with identical, similar or different assembly.

A major disadvantage of this composition is that the pump head can be removed only together with the driver from the housing. This means that the pump head replacement routine to keep treatment that is as clean and aseptic as possible is costly, inconvenient and impractical.

The present invention relates to a liquid moving device which comprises a pharmaceutical product in dissolved or suspended form, said device consisting inter alia of at least

a) an engine;

b) a reservoir;

c) a pump head which is driven by the motor of a) and through which the liquid is transported out of the reservoir;

d) electronic control devices;

where the pump head is equipped with detachable and reconnectable interfaces to the a) motor and / or the b) reservoir and / or the d) electronic control devices.

A device consists of one or more components connected to

together and serve a particular purpose. The goal can be set by a particular use type. One purpose is, for example, the use to inject a pharmaceutical product, in particular to inject insulin into a human or animal body.

The interface between the pump head and the motor functionally connects the two parts. Said functional connection involves the movement of the motor being converted into pumping work. For this purpose the motor can be supplied with energy in several ways. Preference is given in this regard to operation by means of a battery (for single use or rechargeable use) or by means of domestic current, possibly via an adapter adapted to adjust the voltage and / or by solar cells. The pumping work is to transport liquid out of the reservoir. For this purpose there is an interface between the pump head and the reservoir. Said interface is designed such that the movement of the liquid to carry the liquid out of the reservoir may be initiated, maintained and interrupted by appropriate operation or control of the motor and / or pump head. Tubes are included in said interfaces. Connections must be designed to be fluid tight. There is an additional interface between pump head and electronic control devices. Said interface serves to transmit sensor data, for example from a flow sensor, temperature sensor, “glucose sensor” or other sensors, to the electronic control devices. The interface can be provided with an electrical, optical, wireless configuration. Electronic control devices can be used to maintain the operating state of the device, the coordination of the various components, the exchange and processing of operational data between the various components, the exchange of information and user input or monitoring. normal operating and user safety functions.

The pump head interfaces to the engine, reservoir and electronic control devices are distinguished by being quick and easy and reconnectable. The qualification for easy release and connection 30 refers to an average device operator who has previously described the description that may have been included. Simply releasing an interface can be accomplished by, for example, disengaging the parts, pressing and subsequently rotating the parts, moving a lever, sliding a slider, or pressing a button to release from a mechanism. also by unscrewing, uncoupling or the like. Simple connection of interfaces can occur, for example, by pushing, sliding, twisting, bolting, coupling, coupling, lever deflection or the like. The simple release and connection of an interface exists in particular when the release and connection occurs not with the help of a tool but solely by employing the physical resistance of the person (eg a patient, member of the medical staff), in particular. 10 Iar resulting from the movements of the arms, hands and / or fingers.

The present invention is a preferred embodiment of a device as described above wherein the pump head is exchanged after operation (i.e. device actuation) with another pump head.

The pump head is replaced in particular each time, or

even every second, third, fourth, fifth, sixth, seventh, eighth, ninth, tenth or longer interval in each case after use of the device in a pump head “on, hold and off” cycle for operation. The pump head is changed whenever pumping capacity 20 decreases. Especially in use cases where the value is set on cleaning and / or the minimum number of microbiological organisms (eg medical treatment), the pump head should be changed frequently, ie each time or every second time after use.

The present invention is a further preferred embodiment of a device as described above wherein the pump head carries a needle. A needle means an injection needle for medical use. A needle includes a cannula (usually made of metal) through which liquid or gas may be injected or aspirated into / out of the human or animal body, and a holding device 30 which is fixed over the cannula and by which the needle can be attached to the syringe, a catheter, a medical pump, a medicine pen (eg insulin pen) or other medical device. The needle carried by the pumphead is in particular for injecting liquid from the reservoir (eg, insulin preparation) into a human or animal body.

The present invention is a further preferred embodiment of a device as described above wherein the motor consists of a micromotor. A micromotor is distinguished by small dimensions. Its length is between 3 cm and 0.5 cm, its width is between 0.5 cm and 1.5 cm and its height is between 0.5 cm and 1.5 cm. A micromotor for use in the device according to the present invention is based in particular on an electromagnetic driver.

The present invention is a further preferred embodiment of a device as described above, wherein the reservoir consists of a commercially offered cartridge for receiving a medicament. Said cartridges are available for various pharmaceutical products. Known cartridges (also called vials) are those that comprise insulin of various types (eg slow acting such as Lantus or fast acting as Apidra or normal acting as Insuman) or quantities (eg 100 mg). IU, 200 IU, 300 IU, 500 IU, 1000 LU. Or other quantity) as a solution or suspension and as a mixture of different insulins. Insulin cartridges (insulin vials) are used to inject insulin through syringes and insulin pens into the human body or to continuously supply insulin to the human body via insulin pumps. One manufacturer of said insulin cartridges is Sanofi-Aventis in particular. Commercial supply of insulin cartridges usually occurs through pharmacies in most countries.

The present invention is a further preferred embodiment of a device as described above wherein the liquid comprises insulin. Insulin present may be of various types (e.g. slow acting such as Lantus or fast acting such as Apidra or normal acting as Insuman) or quantity (e.g. 100 LU., 200 LU., 300 LU., 500 IU, 1000 LU. Or other quantity) as a solution or suspension and as a mixture of different insulins. Insulin may be of animal origin or be produced by genetic manipulation.

The present invention relates to the use of a device in one or more of the embodiments as described above for injecting a substance into a human or animal body. Said substance is in particular insulin in solution or as a suspension. An injection in this regard should be distinguished in particular from supply by means of a pump. In injection, the substance is introduced into the body within a short period of time (eg 5 to 60 seconds) via a syringe or a medicine pen (eg insulin pen), usually

as a previously fixed total volume. The medicine pen comes in contact with the body only during direct injection. A substance is supplied by a drug pump for a longer period (from 60 seconds to several hours), and the drug pump is usually attached to the body.

The present invention further relates to the production of a

device in one or more of the embodiments as described above, where

a) an engine is provided;

b) a reservoir is provided;

c) a pump head is provided;

d) the individual constituents according to a) to c) are assembled

to provide a functional unit.

Assembly of the device according to the present invention to provide a functional unit means the production of a device according to the present invention in a ready for operation state.

ration. The functional unit of the device according to the present invention is capable, after commencement of the particular operation, to remove liquid from the reservoir by the action of the motor driven pump head. Said removed liquid may, in an additional possible use of the functional unit, be injected by the latter into a human or animal body.

The present invention also relates to a medical device.

for injecting a pharmaceutical into a human or animal body, comprising inter alia a) a housing and / or

b) an adjustment mechanism for presetting an amount of the pharmaceutical to be shipped by the medical device, and / or

c) a screen and / or

d) a release mechanism for initiating and performing the injection;

which additionally comprises at least one device according to the present invention in one or more of the embodiments as described above.

A medical device for injecting a pharmaceutical product is in particular a pen. Pens are particularly known for injecting insulin (insulin pen). Insulin pens are available at pharmacies. Examples of insulin pens currently on the market are Opti- click, Optipen Pro, Optiset, and third-party insulin pens.

A housing is the outer cover of said medical device 15, which may include a protective cap, depending on the design. The housing can be made from plastic or metal. It is generally provided with an elongated shape, generally comprises recesses, holes or windows, includes an internal cavity and is suitable for receiving and positioning additional components.

An adjustment mechanism makes it possible to preset a

amount of a pharmaceutical product to be injected later. The adjusting mechanism can be operated mechanically or electronically. The adjustment mechanism is designed so that the preset amount of the pharmaceutical can be corrected until the current injection is performed.

The screen serves to represent the preset amount of the pharmaceutical product to be injected. The screen may occur in mechanical form or as an LCD screen. The release mechanism includes any air bubble removal that is required prior to performing the current injection, and the start of the injection process until the injection is completed by proper motor and / or pump head drive. The medical device according to the present invention may comprise a second or additional screens.

The first or second or additional screens can be used to represent the current status of the device during injection, eg residual amount remaining, temperature, glucose level, etc. Said screen 5 may, for example, represent the progress of the injection by means of the progress bar.

A medical device as described above preferably includes at least one means for storing and / or processing data and / or signals, and at least one interface for transferring data and / or signals 10 to and / or from a external technical unit (consisting, for example, of the PC on which a program for storing and / or processing data and / or signals is installed which is configured to store and / or process data and / or signals.

A medical device as described above exists in particular for injecting insulin, or GLP-1 or a heparin such as, for example, Venoxox. Insulin may be a long acting, short acting insulin, and a mixed insulin or a normal acting insulin of animal or human origin or one that has been produced conventionally or by genetic manipulation, and may be in the form of a solution or suspension. The medical device according to the present invention in a

or more of its modalities may be used for the prophylaxis and / or therapy of a disease and / or body dysfunction through a substance whose pharmacological activity is reduced or lost in the gastrointestinal tract.

The medical device according to the present invention in one or more of its embodiments may be used in particular for the treatment of diabetes, for example by the administration of GLP-1.

The medical device according to the present invention in one or more of its embodiments may additionally be used to administer a peptide hormone (e.g., glucagon, thyroxine, pituitary hormone, hypothalamus hormone, inter alia Ieptin) or a hormone. growth factors (eg human growth hormone).

The medical device according to the present invention in one or more of its embodiments may additionally be used to administer a heparin (e.g., low molecular weight heparin) and / or Venenox.

Finally, the medical device according to the present invention in one or more of its embodiments may be used to administer a vaccine (e.g., live or dead vaccine; vaccine for the treatment of influenza, measles, mumps, polio, rabies, tetanus, pertussis, inter alia immunodeficiency diseases) and / or to administer antibodies (eg monoclonal or polyclonal antibodies to treat a bacterial infection).

viral infection, immune system dysfunction, allergy, cancer inter alia).

The present invention further relates to the manufacture of a medical apparatus for injecting a pharmaceutical into a human or animal body, where

a) a housing is provided;

b) an adjustment mechanism is provided for presetting

a quantity of a pharmaceutical product to be shipped by the medical device;

c) a screen is provided;

d) a release mechanism is provided;

e) electronic constituents are possibly provided;

f) a technical device as claimed in one or more of claims 1 to 7 is provided;

g) the individual constituents as described in a) to f) are assembled to provide a functional unit.

A device consists of one or more components and serves to

a particular medical purpose, in particular injection of a substance into a human or animal body. A component consists of one or more elements and serves to conform to a technical or non-technical function. A function is technical if it refers to force transfer,

work, energy, material (substance), data and / or signals, maintenance of the structure and / or shape or storage of a substance, or storage of information. A function is not technical if it refers to the input or output of information by the device user or a substance by the device user or substance.

A component may be, for example, part of a technical apparatus that provides a partial function relative to the overall function of the apparatus.

A component is, for example, a reservoir. Reservoir may be a replaceable cartridge comprising a substance (in particular a medicament such as, for example, insulin). A replaceable cartridge may be suitable in particular for use in an insulin pen or other device for injecting a drug into a human or animal body. Another example of a technical component is a pumping device or a pump. Additional examples of technical components are in particular syringes, needles, stem seals, measuring units, measuring screens, tubes, seals, batteries, engines, transmissions, electronic screens, electronic memories or electronic controls. The objective meaning in relation to the technical device is intended in particular to be the movement of liquid from one place to another. A goal is, for example, set by moving a net volume from a reservoir to an external flow line. The goal may also be the injection of a drug into a human or animal body.

A component may be technically connected to one or more other components to meet a joint purpose. A technical connection is, for example, the connection of components that are suitable for transmitting force, work, energy, material (substance), data and / or signals. The components may be connected, for example, by means of a mechanical coupling, a fixed mechanical connection (gluing, bolting, riveting, connecting or the like), a sprocket, a lock, an interlocking means, a metal wire, an optical waveguide, a radio connection, an electromagnetic field, a light beam, or the like.

Injection is the introduction of substances, in particular liquids, by means of a cannula together with a syringe or functionally comparable device such as in particular a pen into a human or animal body. Inter alia, subcutaneous, intramuscular, intravenous, intracutaneous and intraarticular injection is known. Subcutaneous injection occurs under the skin and is relatively easy to perform, not too painful and can be performed 5 by the patient himself. Intramuscular injection occurs within a muscle. Since there are greater risks in such cases, such as, for example, painful periosteum damage, this is usually performed by the medical team. Intravenous injection occurs following venipuncture directly through a vein.

In intracutaneous injection, a pharmaceutical product is passed

right under the dermis. In intra-articular injection, a liquid is injected into a joint. Injection of a substance into a human or animal body should be distinguished in particular from the introduction of a substance through a drug pump, an infusion or other continuous supply that occurs at a given time.

The cannula is essentially a hollow needle that is generally made from metal (eg steel, stainless steel, gold, silver, platinum). The end of the cannula is often sharpened by grinding at an angle. The cannula can be pointed and / or sharp at one end.

and blind at the other end, but it can also be pointed and / or sharp at both ends. The cannula is provided at one end with a generally conical fixation made from, for example, plastic by means of which the hollow needle can be arranged, for example, by pushing or screwing into a medical device such as such. for example a syringe, a medicine pen, in particular an insulin pen, a medicine container or a medicine pump. The cannula serves, in functional interaction with a syringe, pen, pump or other medical device suitable for the purpose, to remove or supply a liquid from or into a human or animal body.

The diameter of the cannula (outside diameter) is generally determined in mm or caliber (caliber 18 = 1,2 mm; caliber 20 = 0,9 mm; caliber 21 = 0,8 mm; caliber 22 = 0,7). caliber 23 = 0,6 mm caliber 25 = 0,5 mm caliber 27 = 0,4 mm). Another parameter to characterize the cannula is its length. Typical cannula lengths are 40 mm, 30 mm, 25 mm,

8 mm, 6 mm and other lengths.

5 A medical device is in particular a device for injecting the

substance in a human or animal body. In addition to a syringe, it is possible for said injection device to be a medicine pen such as, for example, an insulin pen. Medication pens are suitable in various forms and for various purposes and are capable of being marketed from various manufacturers (eg, Optiklick, Optipen, Optiset).

Each insulin pen must meet a variety of ease-of-operation needs in order to make safe and fault-free use possible. The basic need is a screen of the preselected dose 15 and the amount remaining in the cartridge. Dose adjustment and completion of the injection process should be additionally made audible, noticeable by touch and visible. This need for safety stems in particular from the limited perception capacity of elderly patients with type 2 diabetes.

In addition to needle insulin pens, they are also used

for insulin therapy are needle-free injection systems. A current example of the use of the needle-free injection system is the Rõsch AG Injex injection system. With said injector, extremely high pressure is used to inject insulin through a microneedle into the adipose layer of the skin. An elastic spring that is manually tensioned prior to injection stores the necessary injection energy for this. The injected material is in this case distributed evenly and conically in the adipose tissue.

A not insignificant advantage of said apparatus is the injection of the needle-free drug, which for some patients reduces the psychological inhibition threshold for insulin administration. Additionally, needle-free injection prevents puncture field infection. Disadvantages compared to conventional insulin pens were observed to be the transfer of insulin to special cartridges, the comparatively larger mass of the apparatus, and the inclusion of additional spring tensioning accessories.

5 Insulin pumps differ from insulin syringes by

be fully automatic infusion systems for continuous subcutaneous insulin injection. They are approximately the size of a cigarette pack and are permanently used in the body. Short-term insulin is injected through a catheter and a needle 10 located into the skin into the skin tissue according to the patient's pre-established program. The task of the insulin pump is to mimic the continuous emission of insulin by the pancreas to reduce blood glucose level, but without being able to regulate blood glucose with closed loop control. Because of the continuous and adaptable supply of insulin, these pumps have particular advantages for people engaged in sports and whose daily routine varies greatly. It is possible with insulin pump therapy to compensate for large variations in blood glucose, for example, in diabetics with a pronounced DAWN phenomenon, which can be controlled with conventional methods with greater effort. A disadvantage is that when insulin supply is disrupted due to the lack of an insulin reservoir in the human body, severe metabolic disruption may occur. Insulin pumps are available in a variety of technical configurations, and devices with syringe-like containers became established 25 during technical development. In analogy to needle insulin pens, insulin is present in a moving stop reservoir. The latter is driven by a motor driven piston rod.

Due to the fully automatic and continuous insulin delivery, the pumps are provided with a large number of safety systems to protect the user from malfunction with serious consequences. However, this does not mean that responsible and preventive use of the device is unnecessary. Based on current injection devices and further development in medical and microsystem technology, there is a clear trend towards fully automatic miniaturized drug measurement systems. Further development may be towards direction 5 of implantable and extracorporeal drug measurement systems. The goal of implantable insulin pumps is to release the diabetic from a daily insulin injection without the need to wear an external device on the body.

Insulin pens are concentrated on the essential ergonomic and safety features of the EN ISO 11608 standard. This likewise includes geometric / material properties of insulin cartridges and pen needles. The handling and operation of the pen is thus substantially uniform and model independent for the user.

The content of EN ISO standard 11608 where it refers to insulin pens, insulin cartridges and needles is expressly incorporated herein by reference.

In the design of the pens there are some considerable differences to note in the pens of the various manufacturers. The reasons are, for example, the assignment to different target groups (children, elderly people). Due to the requirements of the EN ISO 11608 standard, differences are confined in particular to an injection mechanism and a release mechanism. The dose selector and dose screen are mostly subject to ergonomic needs and result from the general configuration conditions of the respective model.

The essential functional element of an insulin pen is the

injection mechanism. It determines the type and size of pen and the setting of the release mechanism and dose selector. The mechanism transfers the preset dose to the dose selector with the injection energy derived from the release mechanism in one injection stroke 30 from the cartridge stop. Said energy is transmitted either directly to an injection mechanism or via a motion modifying transmission. It is technically possible for an injection mechanism in the piston rod shape to vary in shape.

In insulin pens currently available on the market, solutions with a rigid configuration (eg, threaded shaft, toothed frame 5) or a flexible one (eg, curved toothed frame, curved compression spring) have become established. Other possible configurations such as telescopic piston rod (eg, screw mechanism, belt and chain drive, hydraulic drive, coupled drive) are not employed in the currently available insulin pens 10.

Rigid and flexible type configuration solutions vary greatly and depend on the type of pen, ie reusable pens or pre-filled pens. Piston rods employed are threaded shafts or toothed structures or combinations of the two. In the dose selector, a rotation angle corresponding to the dose is preselected with the aid of detent devices and is transmitted by subsequent screw mechanisms and toothed gears to the injection mechanism and turned into a blow. injection

Drug delivery occurs by specifying an injection stroke and the resulting displacement of the stopper. The amount of liquid sent depends on one injection stroke and the inside diameter of the cartridge. To avoid dosing errors, the air bubbles must be completely removed in accordance with the manufacturer's specifications and EN ISO 11608. In addition, after sufficient liquid delivery, a sufficiently long time must be allowed to elapse. ensuring a stable state, that is, normal fluid pressure and relaxation of the cartridge stop.

The drug reservoir (also referred to as a cartridge) influences the construction and functional structure of the medication pen. Partial functions that can be distinguished from this are first a protection function for the medicine, then a transport function and finally a coupling function with the medicine pen injection system. The protective function is achieved by the cartridge as a whole, ie by the stop, glass body and sealing disc. The transport function for the drug is conferred by the stopper, which is moved with the help of the injection mechanism and results in a change in the volume of the cartridge. The coupling function to the injection system is finally produced by sealing means (eg sealing disc). In an automatic medicine pen (for example, an automatic insulin pen), injection energy is applied by a director with subsequent transmission. A power supply and control unit are additionally required.

In an injection mechanism according to the present invention

The drug (for example by insulin) is transported not by displacing the stop by an injection mechanism, but by introducing a pump device. The pump device is inserted between the cartridge and the injection system and must be provided with appropriate interfaces.

The pump device may be provided with a flow sensor. It is in direct contact with the drug, for example insulin, thus raising additional needs such as reduced organ counts, sterility, inter alia biocompatibility.

With the application of the said functional principle, numerous

(eg, the liquid pressure in the medicine container) are changed compared to a conventional injection pen (for example, an insulin pen) because a subatmospheric pressure arises when the medicine is sucked.

Insulin cartridges serve as a main packaging.

for the drug and must meet high standards. They refer to the dimensional accuracy of the cartridge in relation to dosing accuracy and compatibility with other components. EN ISO 11608-3 addresses these needs and describes the fundamental aspects and the geometric / material construction without necessarily restricting the shape of the cartridge. The impermeability of the cartridge pharmaceutical product should likewise be ensured. Cartridges consist of a plurality of sub-components. A major one is the pharmaceutical glass cylinder with high neutrality and chemical resistance to insulin. Prior to filling, the surface quality of the cylinder is improved by siliconization. Said surface treatment reduces the sliding and breaking forces of the stopper, increases the dosing accuracy and reduces the dissolution of the glass constituents over a long storage time. The degree of siliconization correlates with the level of stop friction forces, a limit being determined by the sensitivity of insulin to silicone.

The cartridge is sealed at both ends by portions of

elastomeric closure, stop and sealing disc. Crucial points in this regard are the mechanical impermeability demonstrated in various pressure situations, and the microbiological impermeability to all organisms in long term testing. Additionally important points are the maximum allowable stop forces and the number of cannula punctures of the sealing disc.

Pen needles are sterile disposable products used to guide insulin out of the cartridge and into the target tissue. They are subjected, like cartridges, to strict needs by the fact that the actual functionality of the insulin pen is achieved only through cooperation of the two components. The needle consists of a cannula that is fixed at both ends and that fits into a cartridge retaining piece. Optimized cannula grinding makes it possible for insertion into the target tissue to be substantially painless for the patient and to cause only little tissue damage upon removal. Similarly, the cartridge sealing disc is punctured without extensive fragmentation. This is a must because the cartridge impermeability must also be ensured when the needle is regularly changed. The cartridge fixing piece ensures a firm fit in the insulin pen.

Even if the pen needles show signs of wear which are precisely visible to the naked eye after use two or more times, they should nevertheless be changed after each injection for sterility reasons. Additionally, crystallized insulin may block the needle. In addition, air enters the cartridge if temperature changes occur, also causing dosing errors. Thus, a change at a temperature of only 15 K causes about 15 µl of air to enter the cartridge.

Microfluidics is a subsection of microssystem technology and includes the configuration, production, use and investigation of microssystems which manipulate and treat fluid quantities in 10-channel cross sections with dimensions from 1 pm to 1 mm. Microfluidic systems are employed in medical technology, biochemistry, chemical and analytical engineering, and microreaction technology. Such microsystems may be dimensioned in the range of millimeters to centimeters by the fact that it is the amount of fluid rather than the size of the microfluidic system that is important for practical use. Additionally, said systems present significant differences from conventional fluidic systems due to small fluid amounts and small system sizes. Miniaturization is accompanied by a change in fluid flow behavior by the fact that surface-bound effects and electrostatic and electrokinetic forces dominate. New approaches are therefore required for the configuration, production and characterization of microfluidic components, for example micropumps and sensors. The constant energy density of the drives results in a reduction in their productivity so that they are not comparable to the 25 conventional components in the macro sector. For this reason, external drives are often employed and sometimes considerably increase the overall system dimensions. In addition, the physics and chemistry of the particles and molecules to be transported limit the miniaturization of microfluidic components.

Diabetes mellitus is a disorder in which the body is by itself

unable to produce and properly use any or sufficient amounts of insulin. Insulin is required to carry glucose from the blood into the body cells. Blood glucose level is continuously kept constant within narrow limits (60 mg% - 100 mg% or 3.33 mmol / L - 5.55 mmol / L). This occurs through the reciprocal action of both hormones insulin and glucagon.

Diabetes mellitus is diagnosed after obtaining blood through

appropriate laboratory equipment. A high blood glucose level should be detected on at least two different occasions to confirm the diagnosis.

Diabetes mellitus is the term used when the blood plasma glucose level exceeds the value determined in at least one of the indicated cases:

a) Fasting blood glucose - 7.0 mmol / L or 126 mg / dL

b) blood glucose two hours after glucose 75 mg dose (oral glucose tolerance test) -11.1 mmol / L or 200 mg / dL

c) blood glucose 11.1 mmol / L or associated 200 mg / dL

with severe thirst (polydipsia), frequent urination (polyuria) or weight loss.

Untreated diabetes leads to high blood glucose levels which can lead to several late symptoms and consequences such as, for example, polyneuropathy, microangiopathy, macroangiopathy, retinopathy, nephropathy and others. The risk of late diabetes damage is lower when the non-enzymatic erythrocyte glycation (HbA1c level) is lower.

Diabetic coma is an acute complication of life-threatening diabetes. The blood glucose level may in these cases extend above 1000 mg / dL, associated with excessive acidity in the blood (metabolic acidity). Diabetic coma can be induced inter alia by infections, excessive carbohydrate ingestion, alcohol abuse, or incorrect insulin dosing.

A distinction is made between type 1 diabetes and type 2 diabetes. In type 1 diabetes there is an absolute insulin deficiency from the outset and treatment is possible with insulin dosing only.

Type 2 diabetes is characterized by reduced insulin sensitivity and relative insulin deficiency. Type 2 diabetes can usually be initially treated with dietary measures and tablets. Insulin replacement often becomes necessary during the course of the disorder.

Type 2 diabetes has become a prevalent widespread disease.

especially in industrialized countries. Overfeeding, lack of exercise are observed as the main cause. Type 2 diabetes can be effectively countered by exercise training and diabetic measures, especially with the goal of weight reduction. It is also possible in the case of type 2 diabetes to use oral antidiabetic agents such as acarbose, biguanides, sulfonylurea, glitazone and others. Therapy using insulin is required when the blood glucose level can no longer be maintained at or near the normal range with sufficient permanence through these measurements.

Several insulins are available for insulin therapy. An

This distinction is generally made according to the duration of the action or the chemical structure. An insulin analog is provided with different amino acids at individual positions compared to human insulin. Properties can be changed this way.

Rapidly installed insulins include human insulin and di-

fast and short acting insulin analogues such as glulisine (trademark: Apidra), Iispro (trademark: Humalog) and aspart (trademark: Novo Rapid).

Slow acting or extended acting insulin are NPH insulin (human insulin with an extended action by hagedorn hawthorn neutral protamine), zinc insulins and various insulin analogs such as glargine (trademark: Lantus) and detemir (trademark: Le - come).

Also used in insulin therapy are mixed insulin and, recently, inhaled insulin.

Mixed insulins consist of a fast acting insulin and an extended acting insulin in various mixing ratios. Mixtures of 10/90%, 25/75%, 30/70%, 50/50% are usual. Therapeutic insulin should always be accompanied by regular determinations of blood glucose level.

In a conventional insulin therapy, a defined amount of mixed insulin is injected at fixed times. More intensive conventional insulin therapy is predominantly employed for type 1 diabetic therapy. In this case, a basic provider is warranted with an extended acting insulin (basal) and fast acting insulin (bolus) is additionally given on time. of meals.

Continuous subcutaneous infusion of insulin by means of a

The pump is especially suitable for type 1 diabetics. Insulin is not injected but is passed into the body by a small pump. The pump is permanently present in the body. Insulin is delivered through a cannulated catheter. The insulin pump usually sends fast acting insulin at equal short intervals for an extended period of time.

Glucagon-like peptide 1 (GLP1) is, alongside the (GIP) dependent sulfurotropic peptide, one of the most important representatives of incretins. Incretins are produced as hormones in the gut and regulate inter alia the blood glucose level by stimulating the release of insulin into the pancreas.

The amount of intestinal hormones produced depends on the amount of carbohydrates ingested orally. GLP1 level increases much more after oral glucose intake than after intravenous glucose administration. Investigations have shown that intravenous infusion and subcutaneous injection of GLP1 in type 2 diabetics leads in many cases to complete normalization of blood glucose level. One problem is that GLP1 is inhibited within a very short time by dipeptidylpeptidase IV (DPP-IV). Subcutaneous injection of GLP1 can maintain effective plasma concentrations of only about 1 -

2 hours. Solution towards the persistent effect of GLP1 can be discovered in the development of longer acting GLP analogs or inhibition of DPP-IV by pharmaceuticals.

Growth hormones are substances that stimulate development in humans, animals and plants. Known examples are somatotropin (human), bovine somatotropin (cattle) and auxin, gibberellic acid (vegetable).

Somatotropin (STH) is also known under the names human growth hormone (HGH) and growth hormone (GH). STH is a peptide hormone with 191 amino acids. Production occurs in the anterior pituitary under the control of somatotropin release factor (SRF; GHRH; GRF) from the hypothalamus. STH is absolutely necessary for

normal linear development. Reduced production or reduced cell response to STH results in short stature. Overproduction results in gigantism or acromegaly.

Short stature due to growth hormone deficiency was treated some years ago by the administration of STH. It was initially obtained from pituitary cadavers before it became possible to produce STH by genetic manipulation in 1985.

Interferons are produced as tissue hormones by human or animal eukocytes, fibroblasts, or T lymphocytes. An interferon is a protein or glycoprotein with an immunostimulatory (eg antiviral) or antihormonal effect. Interferons are divided into alpha-interferons, beta-interferons and gamma-interferons. Interferons are capable of being obtained from various manufacturers for indications such as viral diseases (eg SARS), cancer, multiple sclerosis, hepatitis B / C, hepatitis C.

The vaccine is a composition produced biologically or by genetic manipulation and comprising inter alia individual proteins and / or RNA or DNA fragments and / or exterminated or attenuated pathogens (e.g. influenza, SARS, chicken pox virus, measles pathogens, mumps, rubella, polio, pertussis pathogens).

Known types are live vaccines (eg cowpox), live attenuated vaccines with attenuated viruses or bacteria (eg MMR vaccine, yellow fever, polio) and killed vaccines with inactivated or dead viruses or bacteria or constituents of the same (eg influenza, cholera, bubonic plague, hepatitis A).

Heparins are substances employed therapeutically to inhibit blood clotting. Heparins consist of each case of

alternating sequences of D-glucosamine and D-glucuronic acid or L-iduronic acid. Chain lengths consisting of 5 units may be sufficient for anticoagulation.

Polysaccharide chains have a molecular weight between 4000 and 40 000. In addition to unfractionated heparins, use is also

It is made of low weight fractional heparins with a molecular weight of about 5000. Heparins are not absorbed by the gastrointestinal tract but must be administered parenterally. Heparins act by binding to antithrombin III and thus accelerating the inactivation of activated clotting factors.

Lovenox (also known as clexane) is a preparation

commercially available pharmaceutical ingredient with the pharmacologically active ingredient enoxaprine sodium. The active ingredient is one of low molecular weight heparins with a linear dose-response relationship and a constantly high bioavailability.

Areas of indication for Lovenox are primary prophylaxis of

deep vein thrombosis, deep vein thrombosis therapy with or without pulmonary embolism, unstable angina pectoris and so-called non-Q-wave unstable myocardial infarction therapy, and thrombosis and anticoagulation prophylaxis during hemodialysis.

Examples

The insulin pen consists of a main pump head device that can be changed. The main device is reusable. It consists of a housing in which the pump driver, sensors, electronics and power supply are accommodated (figure 1; figure 2;

figure 3). It is additionally provided with interfaces for external devices, and with a start button and a measuring button. The pump head is a disposable part and is only used for a short time (1-3 days). It has interfaces with the main device and the pen needle (figure 4).

Exchangeable pump head

The pump head consists of a pump chamber (tube pump) and a flow sensor (thruster gauge) which are accommodated in a housing. The housing is provided with interfaces which can easily be separated and closed again (figure 5).

The flow sensor in the present embodiment is separated into two components. In the pump head there is an impeller that can be produced

at a reasonable cost (test object). The same is changed together with the pump head. Wheel rotation is detected with a split switch that is firmly integrated into the main apparatus (figure 6). The flow sensor may also be present in a part, in which case it is either integrated in or separated from the pump head.

List of Figures:

Figure 1: Front view of the insulin pen (dimensions: about 120mm x 45mm x 20mm)

Figure 2: Rear view of the insulin pen

Figure 3: Individual Insulin Pen Components

Figure 4: Pump Head Interface

Figure 5: Exchangeable pump head Figure 6: Impeller with switch Explanation of reference numbers

1 - insulin

2 - basic body (underside)

3 - pump head capable of being replaced

4 - basic body (top side)

5 - cartridge compartment cover

6 - cartridge compartment

7 - cartridge

8 - Cartridge Preview Window

9 - basic body connector for replaceable pump head

10 - retainer between basic body and pump head capable of being replaced

11 - engine

12 - motor coupling

13 - switch

14 - LCD electronics (back side)

15 - LCD screen

16 - camera battery 17 - PC interface

18 - power key

19 - start button

20 - Dosing Button

21 - contact area of exchangeable pump head and base body

22 - coupling to the pump

23 - Cartridge Interface

24 - needle interface

25 - needle

26 - retainer between base body and pump head capable

to be exchanged

27 - Replaceable part of pump head base (outside)

Claims (27)

1. Liquid moving device which comprises a pharmaceutical product, the technical device comprising at least a) an engine; b) a reservoir; c) a pump head which is driven by the motor of a) and through which the liquid is transported out of the reservoir; d) electronic control devices; where c) pump head is equipped with detachable and functionally reconnectable interfaces to a) motor and / or b) reservoir and / or d) electronic control devices. Technical device according to claim 1, wherein the pump head can be easily exchanged for another head pump. Technical device according to claim 1 or 2, wherein the pump head comprises a flow sensor and / or flow sensor components. Technical device according to one or more of claims 1 to 3, claim 1 or 2, wherein the pump head carries a needle. Technical device according to one or more of Claims 1 to 4, wherein the motor consists of a micromotor. Technical device according to one or more of claims 1 to 5, wherein a reservoir is a commercially offered cartridge for receiving a medicament. Technical device according to one or more of claims 1 to 6, wherein the reservoir comprises insulin. Use of a device as defined in one or more of claims 1 to 7 for injecting a substance into a human or animal body. Production of a device as defined in one or more of claims 1 to 8, wherein a) a motor is provided; b) a reservoir is provided; c) a pump head is provided; d) the individual constituents as described in a) to c) are assembled to provide a functional unit. A medical apparatus for injecting a pharmaceutical into a human or animal body, comprising inter alia a) a housing; b) an adjustment mechanism for presetting an amount of the pharmaceutical to be shipped by the medical device; c) a screen; d) a technical unit in the form of a release mechanism for initiating and performing the injection; which additionally comprises at least one device according to one or more of claims 1 to 7. Medical device according to claim 10, wherein the screen consists of an LCD screen. Medical apparatus according to claim 10 or 11 which comprises at least one means for storing and / or processing data and / or signals, and at least one interface for transmitting data and / or signals to and / or from an external technical unit which is configured to store and / or process data and / or signals. A medical device according to claim 12, wherein the external technical unit consists of a PC on which a program for storing and / or processing data and / or signals is installed. Medical device according to one or more of claims 10 to 13, wherein the substance intended for injection consists of insulin. A medical device according to claim 14, wherein the insulin is a long-acting and / or short-acting insulin. Medical device according to one or more of claims 10 to 13, wherein the substance intended for injection is GLP-1. A medical device according to one or more of claims 10 to 13, wherein the substance intended for injection consists of a heparin. Production of a medical apparatus for injecting a pharmaceutical into a human or animal body as defined in one or more of claims 9 to 16, wherein a) a housing is provided; b) an adjustment mechanism is provided for presetting an amount of a pharmaceutical product to be shipped by the medical device; c) a screen is provided; d) a release mechanism is provided; e) electronic constituents are possibly provided; f) a technical device according to one or more of claims 1 to 7 is provided; g) the individual constituents as described in a) to f) are assembled to provide a functional unit. Use of a medical device according to one or more of claims 10 to 13 for the prophylaxis and / or therapy of a disease and / or dysfunction of the body by a substance whose pharmacological activity is reduced or lost. in the gastrointestinal tract. Use of a medical device as defined in one or more of claims 10 to 13 for the treatment of diabetes. Use of a medical device as defined in one or more of claims 10 to 13 for administering insulin. Use of a medical device as defined in one or more of claims 10 to 13 for administering GLP-1. Use of a medical device as defined in one or more of claims 10 to 13 for administering a peptide hormone. Use of a medical device as defined in one or more of claims 10 to 13 for administering a growth hormone. Use of a medical device as defined in one or more of claims 10 to 13 for administering a heparin. Use of a medical device as defined in one or more of claims 10 to 13 for administering Lovenox. Use of a medical device as defined in one or more of claims 10 to 13 for administering a vaccine.